Siemens Healthcare recalls Dimension TSHL reagent cartridges due to incorrect biotin interference levels in instructions. Affected lots may cause inaccurate thyroid hormone test results.
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.
Siemens Healthcare is recalling Dimension TSHL reagent cartridges because the instructions incorrectly list biotin interference levels. This could lead to inaccurate thyroid hormone test results if the cartridge is used.
The instructions for use incorrectly state the biotin level that doesn't interfere with test results. This could cause inaccurate thyroid hormone measurements if the cartridge is used with samples containing biotin.
Lab users who test thyroid hormones with Dimension TSHL cartridges may be affected. Those using the affected lots for testing are most at risk.
Check for lot codes: EB7276, EC7298, EA7318, EB7346, EC734: EA8012, EA8033, EA8051, EC8080, EB8107, EB8121, EA8143, EB8143, EA8177, EB8177, EB8199, EA8223, EA8241, EA8261. The product is a Dimension TSHL Flex reagent cartridge for thyroid-stimulating hormone testing.
Identify the lot code on the cartridge to see if it matches the affected lots listed.
The instructions for use incorrectly state the biotin level that doesn't interfere with test results, which could cause inaccurate thyroid hormone measurements.
The recall record does not specify a remedy, so check with Siemens Healthcare for guidance.
This cartridge is used for thyroid-stimulating hormone (TSH) testing in Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS tests.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1668-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1668-2018 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
